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Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone (AWAOMI2)

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ClinicalTrials.gov Identifier: NCT03370705
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Poseidon CRO
Information provided by (Responsible Party):
Alfa Wassermann Tunisia

Brief Summary:
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Obstructive Disease Drug: Sulodexide Drug: Statin Drug: Antiplatelet Agents Drug: ACE inhibitor Phase 3

Detailed Description:

A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet therapy; plus ACE inhibitor; plus Statin in patients with cholesterol total level > 1,35 g/l) or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).

Criteria for efficacy evaluation are the assessement of the improvement of the Digital Thermal monitoring between base line (day 1) and day 180 measured by Vendys® and the measurement of the correlation between the Digital Thermal monitoring and the following parameters at base line, day 90 and day 180:

  • Von Willebrand factor blood level.
  • Clinical assessment as per pain free walking distance and maximum walking distance, as measured by walking machine.
  • Fibrinogen blood level. Also an assessment of the study medication observance (patient's compliance) will be done.

Safety assessment will be done through the collection of the adverse events occurred during the study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Multicentric open-label controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentric Open-label Randomized Controlled Study for Evaluating the Improvement of Endothelial Function in Stage II Peripheral Arterial Obstructive Disease Patients Treated With Sulodexide + Conventional Treatment {CT] Vs CT Alone
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 30, 2019

Arm Intervention/treatment
Active Comparator: CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
Drug: Statin
Statin 20mg once daily per oral route,
Other Name: Atorvastatin or equivalent

Drug: Antiplatelet Agents
Antiplatelet therapy 75mg once daily per oral route
Other Name: lysine acetylsalicylate or equivalent

Drug: ACE inhibitor
ACE inhibitor 20mg once daily per oral route
Other Name: Captopril or equivalent

Experimental: Sulodexide + CT group

78 patients will be treated by :

  • Sulodexide (250ULS, twice daily , oral administration)
  • Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
Drug: Sulodexide
Sulodexide 250 ULS twice daily per oral route
Other Name: Vessel

Drug: Statin
Statin 20mg once daily per oral route,
Other Name: Atorvastatin or equivalent

Drug: Antiplatelet Agents
Antiplatelet therapy 75mg once daily per oral route
Other Name: lysine acetylsalicylate or equivalent

Drug: ACE inhibitor
ACE inhibitor 20mg once daily per oral route
Other Name: Captopril or equivalent




Primary Outcome Measures :
  1. Change from baseline endothelial function after 6 months [ Time Frame: between base line (day 1) and day 180 ]
    Assess the improvement of the Digital Thermal monitoring measured by Vendys®: evaluation of the improvement of Fingertip Digital Thermal Monitoring (DTM) and the detection of a significant change of the FT2 parameters as per Endothelix discriminative values provided by the manufacturer between day 1 and day 180 (±15 days).


Secondary Outcome Measures :
  1. Metric change of the walking distance [ Time Frame: base line, day 90 and day 180: ]
    Metric variation of the walking distance: Clinical assessment as per pain free walking distance and maximum walking distance, measured by walking machine. A significant change for more than 30% of the walking distance at the assessment point, to consider it an improvement while analysing.

  2. Change in Von Willebrand Factor (VWF) level [ Time Frame: base line, day 90 and day 180 ]
    Evidence of significant change in VWF level: Serum levels of Von Willebrand Factor will be measured by immunoturbidiometric method. An improvement of the level of VWF blood level by at least 10% in 1st assessment and 30% in last assessment compared to baseline values

  3. Assessment of the study medication observance patient's compliance [ Time Frame: 180 days ]
    Compliance will be stated in accordance to the results stated by the patients during remote monitoring at days, 30, 80, 170, and the drug accountability performed by doctors at days 90 and 180. It will be measured in % of the total destined dose expressed in number of intakes and days of treatment.

  4. Assessment of safety [ Time Frame: 180 days ]
    Safety will be assessed by checklist questioning during visits and remote interactions, investigators will be responsible for collection and notification to the Sponsor and authorities in case of Serious Adverse Events.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intermittent claudication.
  • A systolic ankle brachial index ABI < 0. 9
  • An age of over 40 years
  • At least one cardiovascular risk factor (active or weaned Smoking, diabetes mellitus, hypertension, lipid disorders, obesity, and erectile dysfunction) or a history of coronary artery disease or transient ischemic stroke or established.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • withdrawal of informed consent
  • participation in another clinical trial with investigational drugs within the last 12 weeks or during the present trial period
  • history of hypersensitivity to the investigational/conventional drugs
  • Non claudicating patients and patients with critical ischemia
  • Arteritis of non-atherosclerotic origin
  • Patients treated with the oxalate or Naftidrofuryl Pentoxifiline Cilostazol or within 3 months that preceded the inclusion
  • Patients receiving other agents that alter the secretion of NO (such as Sildenafil and Tadalafil) less than 2 weeks before inclusion
  • Patients receiving a regimen based on nitrates or molsidomine or Bosentan
  • Patients receiving Anti Vitamin K medication (AVK)
  • Hemorrhagic accident dating less than 15 days before inclusion
  • Heparin treatment or any treatment by low molecular weight heparins during the study for a continuous period of more than 10 days or a cumulative time during the study for more than 21 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370705


Contacts
Contact: Meriem Ben Touila, MD +21650508872 myriam.btouila@alfasigma.com
Contact: Farah Zribi, PharmD +21650506927 farah.zribi@poseidoncro.com

Locations
Tunisia
InvSite Poseidon0031 Not yet recruiting
Sfax, Tunisia, 3000
Contact: Nizar Elleuche, MD       nelleuche@yahoo.com   
Sub-Investigator: Nizar Elleuche, MD         
Principal Investigator: Imed Frikha, MD         
InvSite Poseidon 0022 Not yet recruiting
Sousse, Tunisia, 4000
Contact: Sofiene Jerbi, MD       jerbisofiane@yahoo.fr   
Principal Investigator: Sofiene Jerbi, MD         
InvSite Poseidon0011 Not yet recruiting
Tunis, Tunisia, 1006
Contact: Melek Ben Mrad, MD       benmradmelek@yahoo.fr   
Principal Investigator: Raouf Denguir, MD         
Sub-Investigator: Melek Ben Mrad, MD         
Sponsors and Collaborators
Alfa Wassermann Tunisia
Poseidon CRO
Investigators
Principal Investigator: Imed Frikha, MD STCCV

Responsible Party: Alfa Wassermann Tunisia
ClinicalTrials.gov Identifier: NCT03370705     History of Changes
Other Study ID Numbers: AP 12016 AW TN
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Acetylsalicylic acid lysinate
Glucuronyl glucosamine glycan sulfate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Protease Inhibitors
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors